Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research

Stroke Clinical Trial

Official title:

Mobile Terminal Based Management and Platelet Reactivity Modified Drug Regulation of Stroke Secondary Prevention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02618265
• Other study ID #: PUTH2013144
• Status: Not yet recruiting
• Phase: N/A
• First received: September 16, 2015
• Last updated: November 27, 2015
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2015
• Source: Peking University Third Hospital
• Contact: Dongsheng Fan
• Phone: +861082265032
• Email: dsfan[@]sina.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators want to verify whether mobile application based on stroke strengthen prevention management is more effective than traditional management model or open stroke management platform. Whole blood-impedance based platelet aggregation(WBA) method and VerifyNow detected by aspirin or clopidogrel responsiveness will provide individualized anti-platelet drug selection. Endpoint event is defined as stroke death or relapse. Primary measure outcomes are change of the stroke recurrence rate and mortality after secondary prevention.

Description:

With high incidence, mortality, morbidity and recurrence rate，stroke has significant impact on national development strategies planning. Improving secondary prevention will strongly promote stroke management in the rapid developing phase of Chinese economy and expansion of health situation. At present lack of high-quality medical resources, low medical permeability cannot remedy extensive prevention failure of stroke. Mobile healthcare is easier to conduct and still in the early stage of explosive growth. This research group has established an open management platform of stroke prevention. And collaborate with Peking University Institute of Information Technology to develop a smart phone application which can be personalized medication reminder, record medication compliance, home blood pressure and blood glucose test results, also can provide doctor-patient communication platform and symptoms alarm. The investigators want to verify whether mobile application based on stroke strengthen prevention management is more effective than traditional management model or open stroke management platform. Whole blood-impedance based platelet aggregation(WBA) method and VerifyNow detected by aspirin or clopidogrel responsiveness will provide individualized anti-platelet drug selection. Control group will be selected from the National Stroke data registration database platform and open platform for stroke prevention. Follow-up period is 2 years. Endpoint event is defined as stroke death or relapse. Primary measure outcomes are change of the stroke recurrence rate and mortality after secondary prevention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• stroke

Exclusion Criteria:

• refusion in research

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Mobile terminal
multiple strategy including mobile terminal based compliance managment, platelet reactivity modified drug adjustment
• traditional management
aspirin or clopidogrel monotherapy or double treatment for
• website platform management
second prevention based on website platform management

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of the stroke recurrence rate	After secondary prevention	2 years stroke recurrence rate	No
Secondary	change of the stroke mortality	After secondary prevention	2 years stroke mortality	No